אחראי.ת רגולציה (זמני) לחברת מדיקל

תיאור משרה

Regulatory Affairs Specialist - Temporary position
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An International Medical Device company Located in Yokneam (North Israel) is looking for a Medical Affairs Specialist responsible for EU, Israel, and China registration.
you will play a pivotal role in ensuring the successful registration and compliance of our medical products in these regions. This position requires a meticulous understanding of regulatory requirements and a proactive approach to maintain and update technical documentation.
Your primary responsibilities will include assessing product changes, maintaining and submitting technical documents, and providing essential support to the local teams in the registration processes of our medical products in Israel and China.
Prepare international documentation to support product registration and changes
internationally.
Works with RA core team members to develop the creation of detailed Regulatory
Plans.
Coordinates the submission of Regulatory documents to regulatory Agencies.
Prepares responses to Regulatory correspondence
Review and approval of new product development and product modification
documentation.
Maintain Regulatory Affairs electronic communications tools, including SharePoint
site, international databases and request tracking systems, and electronic libraries.
Write, review and revise company SOPs as required.
Participates in RA Company Compliance